Quality Assurance Associate
ELITechGroup Inc.
- Bothell, WA
- $30.00-32.00 per hour
- Permanent
- Full-time
- Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.
- Provide Quality support to Manufacturing personnel on the floor; provide guidance during GMP events and initiation of deviation investigations.
- Review deviations, product non-conformities, and GMP investigations to ensure adequate completion.
- Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
- Support the review and approval of incoming raw materials, and calibration of equipment.
- Revise Standard operating Procedures as needed.
- Participates during audits (FDA, ISO, vendor)
- Participate as member of the internal audit team.
- Assists with validating spreadsheets for development and production.
- Assists Document Control, (assign CC and document numbers, assist in obtaining approvals, auditing external documents, etc.) when necessary.
- Other duties and task as assigned.
- Bachelor's degree in relevant science or engineering discipline is preferred. Minimum of Associates degree and/or equivalent combination of education and experience is required.
- Minimum of 2 years' experience in working in a FDA or ISO regulated environment or equivalent training.
- Knowledge of ISO 13485, ISO 9001, cGMP and FDA QSR preferred.
- Hands-on experience with batch record review and product disposition is preferred.